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Fdanewsdevicedailybulletin

Jan. 5, 2005

Vol. 2 No. 3

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CYBERONICS RECEIVES FDA WARNING LETTER

The FDA warned Cyberonics of manufacturing deficiencies at the Houston plant that makes its sole product, the VNS Therapy System - a device that stimulates the vagus nerve to reduce seizures.

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NEOSURG RECEIVES PATENT FOR NEW TIP TECHNOLOGY

NeoSurg Technologies, a developer of minimally invasive access products for laparoscopic surgery, has been granted a patent relating to its bladeless tip technology.

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VISION, MEDTRONIC ENTER DISTRIBUTION AGREEMENT

Medical devicemaker Vision Sciences has entered a distribution agreement with a unit of Medtronic for its Flexible Cystoscope with Slide-On EndoSheath System.

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INTEGRA CLOSES ACQUISITION OF NEWDEAL

Integra LifeSciences, a maker of skin grafts and surgical instruments, has acquired the Newdeal Technologies group of companies for roughly $53 million in cash, subject to certain adjustments.

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BIOSITE FILES PMA FOR TRIAGE STROKE PANEL

Biosite, a research-based provider of novel, rapid medical diagnostics, has submitted a premarket approval application (PMA) to the FDA for the Triage Stroke Panel.

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SUTURTEK ANNOUNCES SERIES B FINANCING

SuturTek, a venture-funded medical device company developing patented safe-suturing devices, recently closed its Series B Financing.

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AMICAS NEW CORPORATE NAME; MEDICAL DIVISION SOLD FOR $100 MILLION

VitalWorks, a leader in radiology and diagnostic image and information technology solutions, has completed the sale of its medical division to Cerner for $100 million in cash pursuant to the definitive agreement signed Nov. 15, 2004.

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CLA DEVELOPS NEW TOOL FOR CHIROPRACTIC ANALYSIS

Chiropractic Leadership Alliance (CLA) developed a new product to enable chiropractors to gain better insight into the function of the nervous system.

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ALLIANCE IMAGING COMPLETES PRIVATE OFFERING

Alliance Imaging, a national provider of diagnostic imaging services, has successfully completed the sale of $150 million in aggregate principal amount of its 7 1/4 percent Senior Subordinated Notes due 2012 in a private placement transaction.

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GEN-PROBE LICENSES TECHNOLOGY FROM ADNAGEN

Gen-Probe licensed technology from AdnaGen, a private company based in Germany, that may help increase the accuracy of molecular diagnostic tests to detect prostate and other cancers, help determine the aggressiveness of these malignancies and monitor responses to therapy.

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DUAL-CHAMBER PACEMAKERS BETTER FOR HEART PATIENTS

Dual-chamber pacemakers may be more expensive than single-chamber models, but they're worth it because they reduce the risk of hospitalization and disability, a new study finds.

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OISI RECEIVES $9 MILLION FINANCING COMMITMENT

Ophthalmic Imaging Systems (OISI), a provider of ophthalmic digital imaging systems, has received a commitment from Boston-based Dutchess Private Equities Fund to purchase up to $9 million of OISI's common stock during a 30-month period.

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